Stryker ACM System nozzle may disassemble during bone cement mixing
The break-away femoral nozzle in Stryker's ACM System may disassemble during use, potentially leaving fragments in the surgical site and causing device failure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential for equipment failure and foreign material in surgical site, but no reported illnesses or injuries. The hazard is stated as potential/theoretical risk, fitting the 'High' category: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Corporation has recalled the ACM (Advanced Cement Mixing) System, a device used during orthopedic joint surgery to mix bone cement with consistent high vacuum. The recall focuses on kits containing the femoral break-away nozzle (applicator tip) that connects the cement cartridge to the mixing system. The affected lot numbers are 22306012, 22307012, 22340012, 22341012, 22342012, and 23017012.
The break-away femoral nozzle may disassemble or break off during use. If this occurs, fragments could fall into the surgical site, potentially causing loss of function of the ACM system and introducing foreign material that could compromise biocompatibility.
Approximately 231 units were distributed in the United States and 21 units internationally to Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Malaysia, Poland, Singapore, South Korea, Spain, Taiwan, Thailand, and the United Kingdom.
The FDA classified this as a Class II recall. Medical facilities and surgeons using this equipment should verify they do not have affected lot numbers in stock. Stryker has contacted affected customers directly. No illnesses or injuries have been reported.
The recalled product
- Product
- Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement with a constant high vacuum through the process. Catalog Number: 0306-705-000
- Manufacturer
- Stryker Corporation
- Hazard
- equipment-failure
- foreign-body-risk
Distribution
Distributed nationwide across the United States.
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